ZORYVE® (Roflumilast) Topical Foam, 0.3% Clears Seborrheic Dermatitis in Individuals Who Previously Reported an Inadequate Response to Topical Steroids

Rhea-AI Summary

Arcutis Biotherapeutics, Inc. announced new data from the STRATUM study, showing that ZORYVE foam was 3.5 times more likely to achieve IGA Success in patients with seborrheic dermatitis who had an inadequate response, contraindication, or intolerance to steroids. The foam also significantly improved quality of life scores, with minimal side effects. The study was presented at the 2024 Winter Clinical Dermatology Conference in Hawaii.

Positive

• ZORYVE foam showed 3.5 times higher IGA Success in patients with seborrheic dermatitis
• Quality of life scores significantly improved with ZORYVE foam
• Minimal side effects and favorable safety profile of ZORYVE foam
• Data presented at the 2024 Winter Clinical Dermatology Conference in Hawaii

Negative

• None.

Dermatology Expert

The efficacy of ZORYVE foam in treating seborrheic dermatitis, particularly in patients who have not responded well to traditional steroid treatments, is a significant development in dermatological therapeutics. The reported 3.5-fold increase in IGA Success rates over vehicle is a strong indicator of the drug's potential to become a preferred treatment option. This is particularly noteworthy given the chronic nature of seborrheic dermatitis and its impact on patients' quality of life.

The improvement in DLQI scores suggests that ZORYVE foam not only addresses the physical symptoms but also enhances the psychological well-being of patients. As a chronic condition, seborrheic dermatitis can cause significant distress, affecting daily activities and social interactions. The rapid improvement in quality of life, with a substantial number of patients experiencing a minimally important difference in DLQI as early as two weeks, could lead to increased patient adherence to the treatment regimen, which is often a challenge in long-term dermatological conditions.

Medical Research Analyst

The statistical significance of the results from the STRATUM study, with p-values well below the 0.001 threshold, indicates a robust differentiation between the efficacy of ZORYVE foam and the vehicle. This level of significance is compelling for both clinicians and patients considering new treatment options. Furthermore, the absence of Serious Adverse Events and the low incidence of Treatment Emergent Adverse Events align with the need for safe long-term treatments for chronic conditions like seborrheic dermatitis.

From a research perspective, these findings could pave the way for further investigation into roflumilast's mechanism of action as a non-steroidal anti-inflammatory treatment. The fact that ZORYVE foam is the first topical drug approved with a new mechanism of action for seborrheic dermatitis in two decades underscores its potential impact on the standard of care in dermatology.

Market Research Analyst

The introduction of ZORYVE foam into the market represents a significant opportunity for Arcutis Biotherapeutics. Given the drug's demonstrated efficacy in a patient population that is often difficult to treat, the potential market share could be considerable. The focus on a steroid-free, once-daily application could resonate well with patients seeking simpler and less burdensome treatment regimens.

Investors and stakeholders should monitor the adoption rate of ZORYVE foam by healthcare providers, as well as patient feedback and long-term outcomes. Market penetration will be influenced by factors such as insurance coverage, pricing strategies and the competitive landscape, including alternative treatments and emerging therapies. The positive data from the STRATUM study is likely to be a key driver in marketing and educational efforts aimed at both clinicians and patients.

• New subgroup analysis from STRATUM study shows that individuals with an inadequate response, contraindication, or intolerance to steroids were 3.5 times more likely to achieve IGA Success with ZORYVE foam than an identical vehicle
  
• ZORYVE foam provided rapid and significant improvement in quality of life scores in patients 17 years and older
• Data presented at the 2024 Winter Clinical Dermatology Conference - Hawaii
  
  

WESTLAKE VILLAGE, Calif., Jan. 14, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced a new subgroup analysis highlighting that adults and adolescents with seborrheic dermatitis who are contraindicated, intolerant, or unresponsive to topical steroids were 3.5 times more likely to achieve IGA Success with ZORYVE^® (roflumilast) topical foam, 0.3%, compared to vehicle (78.8% ZORYVE foam; 48.3% vehicle; p<0.001)ⁱ. ZORYVE foam is a once-daily steroid-free topical for use in all skin and hair types that effectively clears and controls seborrheic dermatitis. Data were presented at the 2024 Winter Clinical Dermatology Conference – Hawaii held January 12-17, 2024, in Honolulu.

Treatment with ZORYVE foam significantly increased the odds of achieving a meaningful improvement in quality of life at Weeks 2, 4, and 8, compared to vehicle as measured by the Dermatology Life Quality Index (DLQI) (odds ratio (OR) 6:97; 95% confidence interval (CI) 3.97, 12.24; p<0.001). DLQI was measured in patients 17 years of age and older. 72.5% of individuals achieved a minimally important differenceⁱⁱ in DLQI score as early as 2 weeks, increasing to 86.6% at the end of the study, Week 8 (compared to 28.1% p=0.001 and 53.6% p=0.001 for vehicle, respectively).

“Seborrheic dermatitis is a chronic, recurrent skin disease that can negatively impact the quality of life of affected individuals, including their self-esteem, emotional well-being, and ability to perform everyday tasks like work or social activities. This new analysis quantifies a meaningful improvement in both the signs and symptoms of seborrheic dermatitis as well as quality of life for individuals treated with ZORYVE foam,” said Matthew Zirwas, MD, founder of the Bexley Dermatology Research Clinic and an investigator in the trial. “As a practitioner, this large subgroup analysis provides me with the confidence to include ZORYVE foam as an important new treatment in my armamentarium to prescribe to my patients, including those who have failed topical steroids which are commonly prescribed for seb derm.”

“This subgroup analysis builds upon the existing evidence for ZORYVE foam as an effective once-a-day treatment option for use in all skin and hair types to clear and control seborrheic dermatitis, including among those who previously experienced inadequate response or intolerance to topical steroids,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis. “As the first topical drug approved with a new mechanism of action for this condition in 20 years, ZORYVE foam represents an important advancement in treatment and addresses a truly significant need in this population.”

ZORYVE foam was well-tolerated with a favorable safety and tolerability profile. Incidence of Treatment Emergent Adverse Events (TEAEs) was low and similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. There were no treatment-related Serious Adverse Events (SAEs). Overall, the most common adverse reactions (≥1%) included nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).

The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) evaluated ZORYVE foam vs vehicle once daily for 8 weeks. The subgroup analysis included 189 adults and adolescents 9 years of age and older with moderate-to-severe seborrheic dermatitis who reported an inadequate response, intolerance, or contraindication to steroids prior to enrollment in the STRATUM study (41.4% of the total study population).

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio including two FDA approved products that harness our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, and X.

INDICATIONS
ZORYVE foam, 0.3%, is indicated for treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.

IMPORTANT SAFETY INFORMATION
ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application.

The most common adverse reactions (≥1%) for ZORYVE foam include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).

Please see full Prescribing Information for ZORYVE foam.

ZORYVE is for topical use only and not for ophthalmic, oral, or intervaginal use.

Forward-Looking Statements
Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential for ZORYVE to simplify disease management for care of seborrheic dermatitis; the potential of real-world use results of roflumilast foam, as well as the commercial launch of ZORYVE in seborrheic dermatitis. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the "Risk Factors" section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 28, 2023, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
asheldon@arcutis.com

Investors
Derek Cole
Investor Relations Advisory Solutions
derek.cole@iradvisory.com

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ⁱ IGA success was defined as at least a 2-point reduction in IGA score from baseline and an IGA score of 0 (clear) or 1 (almost clear)
ⁱⁱ Meaninful important difference defined as at least a 4-point reduction in baseline DLQI score, and achievement of a DLQI score of 0 or 1

FAQ

What is the IGA Success rate for patients with seborrheic dermatitis using ZORYVE foam?

Patients with seborrheic dermatitis who had an inadequate response, contraindication, or intolerance to steroids were 3.5 times more likely to achieve IGA Success with ZORYVE foam compared to the vehicle.

What improvement was seen in quality of life scores with ZORYVE foam?

ZORYVE foam significantly increased the odds of achieving a meaningful improvement in quality of life at Weeks 2, 4, and 8, compared to the vehicle as measured by the Dermatology Life Quality Index.

What were the common adverse reactions to ZORYVE foam?

The most common adverse reactions to ZORYVE foam included nasopharyngitis, nausea, and headache, all with an incidence of 1% or more.

What was the focus of the STRATUM study?

The STRATUM study evaluated ZORYVE foam vs vehicle once daily for 8 weeks in patients with moderate-to-severe seborrheic dermatitis who had an inadequate response, intolerance, or contraindication to steroids prior to enrollment.